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EBV nucleic acid digital PCR detection kit

EUDAMED

Class IVD General (EU MDR)

Ref "Model: EB01-Q24, Specification: 24 Tests Model: EB01-Y24, Specification: 24 Tests"Model EB01-Q24,EB01-Y24,Ref 13763-1Model EB01-Q24

by TargetingOne Technology (Beijing) Corporation

Identity

Trade Name
EBV nucleic acid digital PCR detection kit EUDAMED
Device Name
EBV nucleic acid digital PCR detection kit EUDAMED
Model / Reference
EB01-Q24,EB01-Y24, EUDAMED
"Model: EB01-Q24, Specification: 24 Tests Model: EB01-Y24, Specification: 24 Tests" EUDAMED
EB01-Q24 EUDAMED
13763-1 EUDAMED

Identifiers

Primary DI / UDI-DI
06974689626193 EUDAMED
Basic UDI-DI
B-06974689626193 EUDAMED
EMDN Code
W0105099003 MONONUCLEOSIS (EBV) - RT & POC EUDAMED
W0105040403 EBV - NA REAGENTS EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Finland EUDAMED
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

EBV nucleic acid digital PCR detection kit by TargetingOne Technology (Beijing) Corporation — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
TargetingOne Technology (Beijing) Corporation
EUDAMED SRN
CN-MF-000028247
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (3)

  • EUDAMED 5a750020-499b-4a60-973b-148d6d86acbd 61 fields · synced Jul 14, 2026
  • EUDAMED 5a750020-499b-4a60-973b-148d6d86acbd-1 61 fields · synced Jun 9, 2026
  • EUDAMED c03fdad4-771d-43f2-8e75-bd6bee76d629 61 fields · synced Jul 14, 2026